Recall Z-1004-2012 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Veridex, LLC
CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.
| Date | Feb 13, 2012 (initiated Aug 17, 2011) |
| Status | Terminated |
| Reason | Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II. |
| Root cause | Software design |
| Action | Veridex, LLC sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated August 17, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides procedure sheets with step by step directions for customers to follow. Additionally, a Confirmation of Receipt form was enclosed for customers to complete and return to the firm. Contact Customer Technical Services at 1-877-837-4339 for questions regarding this notice. |
| Quantity | 37 Units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |